Actively Recruiting
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
Led by NaviFUS Corporation · Updated on 2026-04-09
8
Participants Needed
3
Research Sites
141 weeks
Total Duration
On this page
Sponsors
N
NaviFUS Corporation
Lead Sponsor
N
NaviFUS US LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).
CONDITIONS
Official Title
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older at enrollment.
- Diagnosis of drug-resistant temporal lobe epilepsy after failing two adequate anti-epileptic drug trials.
- Focal-onset seizures with no more than two seizure onset zones, at least one in the mesial temporal lobe.
- At least 4 focal-onset seizures with significant symptoms in the 8-week baseline and at least one seizure per month.
- MRI and EEG performed within the past 3 years, with at least one EEG showing focal epileptiform activity.
- FUS treatment area located at least 30 mm beneath the skull bone.
- Stable anti-epileptic drug regimen for at least 30 days before enrollment.
- Negative pregnancy test for females of childbearing potential before first treatment.
- Agreement to use effective contraception from before first treatment to 3 months after last treatment if of childbearing potential or partner thereof.
- Willingness to have hair shaved in the treatment area.
- Ability to complete clinical trial questionnaires in English.
- Ability to provide informed consent and comply with study requirements as judged by the Investigator.
You will not qualify if you...
- Patients with primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures.
- Experienced tonic-clonic status epilepticus within 12 months prior to enrollment.
- Skull area for sonication covered by surgical scars, scalp disorders, or atrophy.
- Presence of clips or metallic implants in skull or brain, except shunts.
- Prior craniotomy site in sonication pathway.
- Acute or progressive neurologic disorders such as brain tumor, multiple sclerosis, dementia, or vascular lesions.
- Implanted electronic devices like pacemakers, defibrillators, pumps, cochlear implants, neurostimulators, or deep brain stimulators.
- Severe depression, active suicidal thoughts or behavior, active psychosis, or psychiatric hospitalization within the past year.
- IQ below 70 measured by standardized intelligence tests.
- Medical conditions that limit study compliance or data interpretation.
- Use of investigational drugs or devices within 4 weeks prior to first treatment.
- Radiofrequency thermocoagulation within 2 months before enrollment.
- History of substance or alcohol abuse within the past year (excluding marijuana).
- Pregnant or breastfeeding women.
- Any condition judged by the Investigator to increase risk or affect study outcomes.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Stanford University School of Medicine
Palo Alto, California, United States, 94305
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
S
Sheang-Tze Fung, Ph.D.
CONTACT
A
Arthur Lung, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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